Roche’s Itovebi Combination Therapy Shows Significant Survival Benefit in Advanced PIK3CA-mutated, HR-positive, HER2-negative Breast Cancer | iPharmaCenter
- ipharmaservices
- Jan 29
- 2 min read
Roche has announced that its investigational drug, Itovebi (inavolisib), in combination with palbociclib and fulvestrant, has demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer.
This finding comes from the phase III INAVO120 study, which previously reported that the Itovebi-based regimen reduced the risk of disease progression or death by 57% compared to palbociclib and fulvestrant alone. No new safety concerns have emerged since the earlier analysis. Detailed results from this overall survival analysis are expected to be shared at an upcoming medical conference.
In October 2024, the U.S. Food and Drug Administration approved the Itovebi-based regimen for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence after adjuvant endocrine therapy. The INAVO120 study's data are also under review by other global health authorities, including the European Medicines Agency.
Itovebi is an oral, targeted therapy designed to provide durable disease control with a favorable safety profile for patients with PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. Its high potency and specificity for the PI3K alpha isoform, along with its unique mechanism facilitating the degradation of mutated PI3K alpha, distinguish it from other PI3K inhibitors.
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The INAVO120 study is a phase III, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Itovebi in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer whose disease progressed during or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. The study enrolled 325 participants, randomly assigned to either the investigational or control treatment arms.
Roche is conducting additional phase III clinical trials to further assess Itovebi in various combinations for PIK3CA-mutated advanced breast cancer and is exploring its potential in other tumor types to address unmet medical needs.
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